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SUMMARY

For some applications of the present invention, a subject is identified as suffering from menorrhagia. An insertion device is manually inserted into the subject's vagina to reduce nitric oxide production by pelvic tissue of the subject. The device is typically inserted by the subject in accordance with a schedule related to the timing of the subject's menstrual period and/or in response to an onset of heavy bleeding or menstrual pain.

Typically, the apparatus is tampon-shaped and comprises a control unit and one or more electrodes. The control unit is configured to drive the electrodes to drive an electrical current into the subject's vagina in order to reduce nitric oxide production by pelvic tissue of the subject.

For some applications, the insertion device is manually inserted into the subject's vagina to enhance nitric oxide production by pelvic tissue of the subject. In one such application, the control unit drives a current into the subject's vagina, generating a release of nitric oxide from the cervix, and/or tissue in the vicinity of the cervix of the subject. This release of nitric oxide causes the cervix to relax slightly, facilitating the release of clots from the uterus, thereby reducing the number of days of bleeding in a period of a subject and/or reducing the pain associated with the period.

In another application, the insertion device is inserted by the subject when the subject is ovulating, or in a window of 2-3 days prior to or following ovulation. The control unit drives a current into the subject's vagina in order to increase nitric oxide production by pelvic tissue, thereby increasing the fertility of the subject.

In an alternative application, the insertion device is automatically or manually activated, or inserted by the subject, in response to a decline in fetal heartbeat. The control unit drives a current into the subject's vagina in order to increase nitric oxide production, thereby increasing blood supply to the fetus or fetuses. In yet another application, the insertion device is inserted by the subject in response to a multiple gestation pregnancy in order to increase blood supply to the fetuses, even in the absence of detection of reduced fetal heartbeat. For some applications, the insertion device is inserted by the subject in order to increase blood supply to a single fetus, even in the absence of detection of reduced fetal heartbeat.

For some applications, one or more electrode units are surgically implanted onto a nerve innervating the uterus of the subject, for example, the inferior hypogastric plexus, the uterovaginal plexus, and/or the pelvic splanchnic nerve. In such applications, the control unit is configured to drive the electrode units to drive a current into the nerve, to reduce nitric oxide production. Alternatively or additionally, the control unit is configured to drive a pain-reduction current into the nerve of the subject to reduce pain associated with menorrhagia.

Although some treatments are described herein as being applied to a subject via electrodes of an insertion device, the scope of the invention includes applying such treatments to the subject via electrodes that are coupled to a nerve. Similarly, although other treatments are described herein as being applied to a subject via electrodes that are coupled to a nerve, the scope of the invention includes applying such treatments to the subject via electrodes of an insertion device.

There is therefore provided, in accordance with some applications of the present invention, apparatus for treating menorrhagia of a subject, including:

at least one electrode, configured to be coupled to a pelvic site of the subject; and

a control unit, configured to reduce nitric oxide production by pelvic tissue of the subject by driving the electrode to drive an electric current into the pelvic site of the subject.

For some applications, the apparatus further includes a sensor configured to sense a level of bleeding of the subject and to generate a signal in response thereto, and the control unit is configured to receive the signal and to reduce the nitric oxide production in response to the signal.

For some applications, the control unit is configured to configure the electric current to have a frequency that is between 50 Hz and 150 Hz.

For some applications, the at least one electrode is configured to be inserted by the subject into a vagina of the subject and removed by the subject from the vagina of the subject.

For some applications, the at least one electrode is configured to be inserted into the vagina of the subject in accordance with a schedule related to timing of a menstrual period of the subject.

For some applications, a total length of the apparatus is 4-10 cm.

For some applications, the control unit is configured to configure the electric current to have an amplitude that is between 1 mA and 15 mA.

For some applications, the control unit is configured to configure the electric current to have an amplitude that is between 5 mA and 15 mA.

For some applications, the at least one electrode is configured to be coupled to a nerve that innervates a uterus of the subject.

For some applications, the at least one electrode is configured to be coupled to a nerve of the subject selected from the group consisting of an inferior hypogastric plexus, a uterovaginal plexus, and a pelvic splanchnic nerve.

For some applications, the control unit is configured to drive a pain-reduction current into the nerve of the subject to reduce pain associated with menorrhagia.

For some applications, the control unit is configured to drive into the nerve of the subject a collision blocking current configured to reduce pain associated with the menorrhagia.

For some applications, the control unit is configured to reduce nitric oxide production by using a first signal protocol, and to reduce pain by driving the pain reduction current into the subject's nerve using a second signal protocol, different from the first signal protocol.

There is further provided, in accordance with some applications of the present invention, a method, including:

identifying a subject as suffering from menorrhagia; and

in response to the identifying:

- driving an electric current into a pelvic site of the subject; and
- configuring the electric current to reduce nitric oxide production by pelvic tissue of the subject.

For some applications, configuring the electric current includes sensing a level of pain of the subject and configuring the electric current in response to the sensed level of pain.

For some applications, the method further includes implanting the electrode in the pelvic site of the subject, and driving the electric current includes driving the electric current via the electrode while the electrode is implanted in the pelvic site.

There is additionally provided, in accordance with some applications of the present invention, apparatus for treating menstrual pain of a subject, including:

at least one menstrual cramp sensor, configured to be coupled to a pelvic site of the subject and to generate a signal indicative of menstrual pain; and

a control unit, configured to receive the signal and to relieve the menstrual pain by driving an electric current into tissue of the subject.

For some applications, the apparatus includes a manual insertion device, which includes the sensor and the control unit.

For some applications, the apparatus is configured to be surgically implanted in the subject.

For some applications, the sensor includes an electrode.

For some applications, the control unit is configured to receive an electromyographic signal from the electrode, which varies in response to menstrual cramps of the subject.

For some applications, the control unit is configured to drive the electric current via the electrode.

For some applications, the control unit is configured to reduce nitric oxide production by pelvic tissue of the subject, by driving the electrode to drive the electric current.

There is further provided, in accordance with some applications of the present invention, apparatus for increasing fertility of a subject, including:

a control unit, configured to increase fertility of the subject by increasing nitric oxide production by tissue of the subject by driving an electric current into the tissue.

For some applications, the apparatus further includes an ovulation sensor, configured to sense ovulation of the subject and to generate a signal in response thereto, and the control unit is configured to receive the signal and to increase the nitric oxide production in response to receiving the signal.

For some applications, the control unit is configured to configure the current to have a frequency that is between 3 Hz and 50 Hz.

For some applications, the control unit is configured to configure the current to have a frequency that is between 10 Hz and 20 Hz.

For some applications, the control unit is configured to configure the current to have an amplitude that is between 1 mA and 7 mA.

For some applications, the control unit is configured to configure the current to have an amplitude that is between 1 mA and 3 mA.

There is further provided, in accordance with some applications of the present invention, a method for increasing fertility of a subject, including:

identifying a subject who wants to become pregnant; and

in response to the identifying, driving an electric current into a pelvic site of the subject configured to increase fertility of the subject by enhancing nitric oxide production by pelvic tissue of the subject.

For some applications, the pelvic site includes a vagina of the subject, the method further includes inserting an electrode into the vagina, and driving the electric current includes driving the electric current via the electrode while the electrode is inserted.

For some applications, inserting the electrode includes inserting the electrode into the vagina of the subject in accordance with a schedule related to timing of ovulation of the subject.

There is additionally provided, in accordance with some applications of the present invention, apparatus for increasing blood supply to a fetus within a subject, including:

at least one electrode configured to be coupled to a pelvic site of the subject; and

a control unit, configured to enhance fetal blood supply by increasing nitric oxide production of tissue of the subject, by driving the electrode to drive an electric current into the pelvic site of the subject.

For some applications, the apparatus further includes a sensor configured to sense a heartbeat of the fetus and to generate a signal indicative of the fetal heartbeat, and the control unit is configured to enhance the fetal blood supply in response to identifying a decline of the fetal heartbeat.

There is additionally provided, in accordance with some applications of the present invention, a method, including:

identifying a subject who is pregnant with a fetus; and

in response to the identifying, driving an electric current into a pelvic site of the subject configured to increase blood supply to the fetus by enhancing nitric oxide production by pelvic tissue of the subject.

For some applications, driving the current includes driving the current even in the absence of sensing a decline in fetal heartbeat within an immediately preceding 30 minute period.

For some applications, identifying includes identifying that the subject is pregnant with more than one fetus.

The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an insertion device, in accordance with some applications of the present invention; and

FIG. 2 is a schematic illustration of a nerve cuff, in accordance with some applications of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made toFIG. 1, which is a schematic illustration of amanual insertion device20 configured to be inserted into a subject's vagina, in accordance with some applications of the present invention.Manual insertion device20 comprises acontrol unit22, which is coupled to one ormore electrodes24 via electrical leads, and is configured to drive the electrodes to drive an electrical current into a pelvic site of the subject, e.g., the subject's vagina. For some applications,insertion device20 is configured to reduce nitric oxide production by pelvic tissue of the subject, by driving the current into the vagina. Typically,manual insertion device20 is tampon-shaped and, for example, about 4-10 cm in length.

For some applications, a subject is identified as suffering from menorrhagia, anddevice20 is inserted as a treatment for the menorrhagia.Insertion device20 is typically inserted by the subject in response to menstrual pain or in accordance with a schedule related to the timing of the subject's menstrual period.

For some applications,device20 comprises asensor23 which is configured to sense the onset of heavy bleeding, and, in response thereto,control unit22 initiates the driving of the current. As appropriate, the sensor may comprise a pH sensor, an electrical sensor, an electromyographic sensor that senses muscle activity associated with menstrual cramps, or a mechanical sensor, each of which is configured to alert the control unit of the initiation of heavy bleeding. Alternatively,control unit22 initiates the driving of the current in response to detection that it is disposed within the subject's vagina. For example,electrodes24 may be coated with a dissolvable coating that dissolves when brought into contact with fluid of the vagina (e.g., vaginal discharge, or blood), and the dissolving of the coating allows the current to flow.

Typically,control unit22 reduces nitric oxide production by the subject's pelvic tissue by drivingelectrodes24 to drive an electric current into the pelvic site of the subject having a frequency of between 50 Hz and 150 Hz, for example, between 50 Hz and 100 Hz. Further typically,control unit22 drives each of theelectrodes24 to drive a current into the pelvic site of the subject having an amplitude of between 1 mA and 15 mA, e.g., between 5 mA and 15 mA.

For some applications,insertion device20 increases nitric oxide production by pelvic tissue of the subject, by driving a current into the vagina. In one such application,insertion device20 is inserted by the subject in accordance with a schedule related to the timing of the menstrual period of the subject, in order to reduce the number of days of the subject's menstrual period. Typically,electrodes24 are coupled to the tampon-shapeddevice20 at its distal tip.

Control unit

22 is configured to driveelectrodes24 to drive an electrical current into the subject's vagina, to increase the nitric oxide production by the cervix and/or tissue in the vicinity of the cervix. This release of nitric oxide in the vicinity of the cervix causes the cervix to relax slightly, facilitating the release of clots from the uterus of the subject, and thereby reducing the number of days and/or severity of the subject's menstrual period. Typically,control unit22 increases nitric oxide production by the subject's pelvic tissue by drivingelectrodes24 to drive an electric current into the pelvic site of the subject having a frequency of between 3 Hz and 50 Hz, for example, between 10 Hz and 20 Hz, and a current of between 1 mA and 7 mA, for example, between 1 mA and 3 mA.

For some applications,device20 is inserted by the subject in accordance with a schedule related to the timing of ovulation of the subject, e.g., within 3 days of the start or end of ovulation. In such an application,device20 is inserted in order to enhance the fertility of the subject, e.g., by increasing blood circulation due to increasing nitric oxide. For some applications,sensor23 is an ovulation sensor that senses ovulation of the subject and generates a signal in response thereto. The control unit receives the signal and increases the nitric oxide production in response to receiving the signal.

For some applications,insertion device20 is inserted by a subject identified as having a multiple gestation pregnancy. In such an application,insertion device20 is inserted in order to increase the blood supply to the fetuses, by enhancing nitric oxide production, even in the absence of detection of a decline in fetal heart rate. For some applications,insertion device20 is inserted in order to increase the blood supply to a single fetus, even in the absence of detection of a decline in fetal heart rate. In another application,insertion device20 is automatically or manually activated, or inserted by the subject, in response to a sensed decline in the heartbeat of a fetus. In one application,sensor23 comprises an ultrasound sensor. In another application, the sensor comprises another suitable sensor for assessing fetal heartbeat. In such an application,insertion device20 is activated or inserted in order to increase the blood supply to the fetus.

Reference is now made toFIG. 2, which is a schematic illustration of anerve cuff30 configured to be coupled to anerve32 innervating a uterus of the subject. For example,cuff30 may be placed around the inferior hypogastric plexus, the uterovaginal plexus, and/or the pelvic splanchnic nerve of the subject. A set of one ormore electrodes24 is disposed on the surface ofnerve cuff30, in contact with or nearnerve32 following implantation.Nerve cuff30 is typically configured to be surgically implanted onnerve32 of the subject, using techniques that are known in the art.

For such applications,control unit22 typically comprises a handheld wand that is activated by the subject in response to the onset of heavy bleeding and/or in response to pain associated with menorrhagia. Alternatively or additionally,nerve cuff30 or another portion of the apparatus comprisessensor23, e.g., a pH sensor, an electrical sensor, an electromyographic sensor that senses muscle activity associated with menstrual cramps, or a mechanical sensor, each of which is configured to alert the control unit of the initiation of heavy bleeding and/or of menstrual pain. In response to the signal from the wand, or from the sensor,control unit22 is configured to treat the pain and/or bleeding by, for example, driving a current viaelectrodes24 intonerve32 of the subject, to reduce nitric oxide production by pelvic tissue of the subject.

Typically,control unit22 driveselectrodes24 to drive intonerve32 an electric current having a frequency of between 50 Hz and 150 Hz (for example, between 50 Hz and 100 Hz). Further typically,control unit22 drives each of theelectrodes24 to drive a current into the nerve having an amplitude of between 1 mA and 6 mA, e.g., between 2 mA and 4 mA.

For some applications,control unit24 is configured to drive a current for reducing pain associated with menorrhagia. In accordance with respective applications, the current may be driven via the set of one ormore electrodes24 coupled tonerve cuff30, or viaelectrodes24 ofinsertion device20. The current is typically driven into a pelvic muscle of the subject (e.g., a pelvic floor muscle), and has different signal parameters from those used to treat menorrhagia. Further typically,control unit24 is configured to drive a collision blocking current to reduce pain associated with menorrhagia.

For some applications, techniques described in the present patent application are practiced in combination with techniques described in one or more of the references cited in the Background section of the present patent application.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.